摘要
Abstract
With the continuous evolution of global regulatory requirements for clinical trials,metadata has become a core element for ensuring the traceability and verifiability of data throughout its lifecycle.The quality of metadata review directly affects the reliability of trial data and its acceptance by regulatory authorities.In response to common industry challenges,such as inconsistent metadata definitions,inadequate blinding protection,weak third-party management,and insufficient adaptation of technical tools,this study systematically constructs a compliant and practice-oriented metadata review framework for clinical trials.The framework is grounded in both international and domestic regulatory requirements,including ICH GCP E6(R3)and China's Guidelines for Computerized Systems and Electronic Data in Clinical Trials(Draft),and is informed by real-world operational experience.The study clarifies the core scope and clinical value of technical,process,and business metadata,and establishes four key review principles:full-scope coverage,multidimensional content,risk-based object classification,and lifecycle-wide implementation.It further elaborates review focus areas across the entire data lifecycle(collection,processing,transformation,storage,archiving,and destruction).In addition,it proposes dedicated metadata review plan for blinded data,third-party management,and tool selection,and puts forward optimization strategies targeting key industry challenges,such as standardized system development,technological enhancement,and workforce capacity building.This framework provides a standardized and practical reference for metadata review in clinical trials,contributing to improved data quality and review efficiency,reduced regulatory inspection risks,and better alignment of clinical trial data governance with international regulatory expectations.关键词
元数据审核/数据完整性/盲态保护/数据全生命周期/监管合规Key words
metadata review/data integrity/blinding/data lifecycle/regulatory compliance分类
医药卫生
